Cyxone is set to initiate a Phase II clinical trial with Rabeximod in moderate Covid-19 patients after it received approval from the regulatory authority and the ethics committee in Poland.
A Phase II candidate drug, Rabeximod is being analysed for the management of rheumatoid arthritis, as well as moderate Covid-19 infections.
The oral treatment is intended to stop progression to acute respiratory distress symptoms (ARDS) triggered by virus-related overactivation of the immune system.
In the double-blinded trial, the efficacy of the drug will be evaluated in 300 patients enrolled with moderate Covid-19 and need oxygen but not ventilator treatment.
Participants will be given either Rabeximod or placebo in the study.
Cyxone anticipates reporting preliminary data from the fully financed study in the third quarter next year.
At present, Cyxone is contracting several clinical sites in Poland with arrangements in place to begin patient inclusion rapidly.
In addition, the company has sought regulatory approval in Slovakia and is planning to seek approval in more countries.
Cyxone CEO Tara Heitner said: “We are pleased to soon initiate our Phase II study in which we aim to develop an oral treatment for moderate Covid-19 patients, preventing the progression to acute symptoms avoiding the need of intensive care treatment and relieving the burden on hospitals and healthcare systems.
“Given a successful outcome, Rabeximod could be developed as a candidate drug not only for Covid-19, but for the treatment of other disorders of the immune system including virally induced acute respiratory disorders.”
The company intends to enter a strategic collaboration with a global pharma firm to further advance the development and commercialisation of Rabeximod in Covid-19, as well as other virally induced respiratory diseases.